It is widely acknowledged that the use of autologous vascular tissue in repair or replacement surgical procedures involving blood vessels, especially small blood vessels (i.e., 5 mm or less) provides long-term patency superior to that of commercially available prostheses. However, the use of autologous vascular grafts (eg. autologous vein grafts used in coronary bypass surgery) is associated with several problems. For example, harvesting of an autologous vascular graft constitutes a serious surgical invasion which occasionally leads to complications. Furthermore, the autologous vascular graft may frequently be unavailable due to specific morphological or pathophysiological characteristics of the individual patient. For example, a patient may lack a length of vein of the appropriate caliber or an existing disease (eg. varicose veins) may result in veins of unsuitable mechanical compliance. In addition to the foregoing, the use of autologous vein grafts for coronary bypass or femoropopliteal bypass or for interposed grafting of arteries frequently leads to development of intimal proliferation which eventually leads to loss of patency.
The experience with autologous vein grafts suggests the need for a suturable tubular product available without invading the patient. This product should be readily available in sterile form and in a large variety of calibers, degrees of taper of internal diameter and degrees of bifurcation (branching). In addition to ready availability and long-term patency, the graft should also remain free of aneurysms, infection and calcification and should not cause formation of emboli nor injure the components of blood over the duration of anticipated use.
The present invention is a blood vessel prosthesis which meets all of the foregoing criteria.